The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
Informed Consent Form (ICF) is signed by Subject.
Age ≥ 18 years at time of informed consent signature.
Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
Patient has a prior visceral artery stenting not associated with registry procedure.
Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion. Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set.
Cohort
Prospective
Not listed
Freedom from Target Vessel Instability
Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture
Target Vessel Technical Success
Successful catheterization and stent placement in all intended target vessels.
Procedural Technical Success
All of the qualifying criteria are met (in the absence of surgical conversion or mortality, type I or type III endoleak, branch occlusion, or graft limb obstruction): * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits at index procedure. * Successful delivery and deployment of the aortic stent graft and all modular stent graft components at index procedure * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels at final completion angiography * Absence of type I or type III endoleaks at final completion angiography that extends beyond 30 days by confirmatory imaging * Patency of all aortic modular stent graft components and intended side branch components at final completion angiography.
Clinical Success
Requires all of the following to be met: * Procedural Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleaks * Absence of aneurysm sac expansion \> 5mm * Absence of device migration \> 10mm * Absence of failure due to device integrity issues * Absence of aneurysm rupture * Absence of conversion to open surgical repair * Absence of permanent paraplegia o Note: defined as spinal cord deficit with inability to walk and not resolving at a future assessment * Absence of disabling stroke o Note: defined as stroke with one of the following: complete hemianopia, severe aphasia, visual or sensory extinction, or any weakness limiting sustained effort against gravity * Absence of new-onset dialysis following the initial operation
Major Adverse Events
Any of the following events: * All-cause mortality * Myocardial infarction (MI): MI resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome * Respiratory failure requiring prolonged (\> 24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline characterized by one or more of the following: * \>50% reduction in baseline estimated glomerular filtration rate (eGFR); or, * New-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Permanent paraplegia * Major stroke. * Note: any stroke that is disabling or fatal
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